(149 days)
The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system.
Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM Module acquires, processes and stores information regarding these parameters.
The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.
The TRAM Module is part of a multi-parameter modular system that measures and processes a patient's physiologic parameters. The TRAM Module works as a component of GE Medical Systems Information Technologies host monitoring systems and does not function on its own. The TRAM Module collects a patient's physiological data and sends it to a GEMS IT bedside monitor for display. TRAM modules incorporate different monitoring capabilities based on their configuration. The TRAM Module can also be used as a transport monitor when used with the Transport Remote Acquisition Module Patient Monitoring System.
The provided text does not contain acceptance criteria or a study that proves the device meets specific performance criteria.
This document is a Premarket Notification 510(k) Summary for the TRAM Module. Its purpose is to demonstrate substantial equivalence to a predicate device, not to present a detailed performance study with acceptance criteria.
Here's what the document does state regarding testing:
- Test Summary: "The TRAM Module and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the TRAM Module: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final acceptance testing (Validation), Performance testing, Safety testing, Environmental testing."
- Conclusion: "The results of these measurements demonstrated that the TRAM Module are as safe, as effective, and perform as well as the predicate device."
Based on the provided text, I cannot complete the table or provide information for the requested points. The document states that performance testing was done, but it does not specify the acceptance criteria for individual parameters (e.g., accuracy of ECG, blood pressure, etc.), nor does it detail the methodology, sample sizes, ground truth establishment, or expert involvement for such tests.
The information provided only confirms that quality assurance measures and various types of testing were performed, leading to the conclusion of substantial equivalence.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.